Effect of Intra-Operative Glove-Changing During Cesarean on Post-Op Complications: A Randomized Controlled Trial [12OP

Abstract

INTRODUCTION: An increasing body of literature suggests that vaginal floral bacteria contribute to post-operative infectious morbidity when introduced to normally sterile environments during cesarean section. Surgeon's gloves, exposed to the lower genitourinary tract during delivery of an infant, may be an important vehicle of bacteria to the abdominal wall. Changing gloves during cesarean prior to abdominal wall closure may decreased bacterial transfer to the wound bed and therefore the incidence of wound complications following cesarean section. METHODS: This is a randomized controlled trial. Women undergoing non-emergent cesarean section were randomized to control conditions or intra-operative glove-changing, which entailed surgeons changing outer sterile gloves prior to abdominal closure. The primary outcome is composite wound complications, defined as the occurrence of seroma, hematoma, wound infection, skin separation of at least 1cm, or other incisional separation or abnormality requiring a bedside procedure Enrollment of 554 patients provides 80% power to detect a 50% reduction in the primary outcome from the approximately 15% incidence noted in the first 100 control subjects studied during a planned interim analysis. RESULTS: Of the first 409 patients analyzed, a significant reduction in composite wound complications is observed in the glove-changing group (11/185, 5.9%) compared to the control group (29/224, 12.9%), with p-value 0.018. At time of this submission, there are 145 subjects remaining to analyze, estimated to complete by December 2016. CONCLUSION: Preliminary analysis of this nearly completed randomized controlled trial indicates a trend toward reduction of composite wound complications following cesarean section when gloves are changed prior to abdominal closure.